LLY - Lilly Incyte's COV-BARRIER study fails to meet primary endpoint in COVID-19

Eli Lilly (LLY) and Incyte (INCY) announces results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg plus standard of care (SoC), including corticosteroids and remdesivir vs. placebo plus SoC.The trial did not meet statistical significance on the primary endpoint - a difference in the proportion of participants progressing to ventilation or death by Day 28.Baricitinib-treated patients were 2.7% less likely than those receiving SoC to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).Baricitinib + SoC resulted in a significant reduction (nominal p-value=0.0018) in death by 38% by Day 28.A reduction in mortality was observed in baricitinib-treated patients and was most pronounced for patients receiving ventilation at baseline (17.5% vs. 29.4% for baricitinib plus SoC vs. SoC; hazard ratio [HR]: 0.52; 95% CI: 0.33, 0.80; nominal p-value=0.0065).

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Lilly, Incyte's COV-BARRIER study fails to meet primary endpoint in COVID-19